General Requirements for Clinical Investigations for the Conformity Assessment Procedure of Medical Devices in accordance with EU Regulation 2017/745 (Medical Device Regulation, MDR)

Clinical investigations are essential studies for evaluating the safety and performance of medical devices as part of the conformity assessment procedure.

In accordance with Article 62 of EU Medical Devices Regulation 2017/745 (MDR), they must pursue at least one main goal:

1. Verification of the intended purpose and performance of the device under normal conditions of use as claimed by the manufacturer,
2. Validation of declared clinical benefits, and
3. Review of clinical safety and evaluation of potential adverse side effects in relation to expected benefits

Important: Article 62 (and up to Article 81) of the MDR also applies to CE-marked medical devices, provided that new intended purpose is to be tested.

Critical aspects of implementing clinical investigations:

• Prioritising subject protection: The rights, safety, and well-being of subjects are top priorities.
• Ethical review: Mandatory review by an ethics committee constituted under the respective national law.
• Subjects' informed consent: Comprehensive information, free and voluntary consent of study participants or their legal representatives.
• Right of withdrawal: Possibility to drop out of clinical investigation at any time without disadvantages for study participants.
• Risk-benefit assessment: Minimise risks and burdens for study participants and outweigh the expected benefits
• Qualified study staff: Care provided by adequately qualified doctors or other authorised health professionals.
• Investigator qualifications: Appropriate scientific and clinical expertise of investigators.
• Infrastructural requirements: Implementation in appropriate facilities similar to clinical use.

Additional regulatory requirements include the protection of particularly vulnerable populations, data protection management in accordance with the GDPR, and ensuring the scientific validity and reliability of the data collected.

Specific aspects include:

• Sponsor responsibility: Sponsors not based in the EU require a Legal Representative in the Union.
• Compliance of the investigational device: Compliance with the basic safety and performance requirements set out in MDR Annex I, with the exception of aspects to be tested.
• Undue influence: Prohibition of unreasonable, in particular financial, incentives to participate in studies.

These comprehensive requirements aim to ensure the ethical integrity, scientific validity, and regulatory compliance of clinical investigatios and thus guarantee the safety and effectiveness of medical devices in the interest of public health.

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Benefit from our many years of experience in designing and carrying out clinical studies /investigations and contact us for an initial consultation.

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